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From CC about GvHD.
“Denis Burger: “Sure. We have an approved protocol with the FDA for a Phase 2 study. It is a 60 patient randomized, double-blind, placebo-controlled multi-center study. We expect to inject the first patients this quarter and we expect that it will take somewhere between 6 and 9 months to fully enroll in general timeline. And we expect that this study will cost somewhere between $3.5 million and $4 million to complete.””
From: https://seekingalpha.com/article/4063244-cytodyns-cydy-ceo-nader-pourhassan-hosts-investment-community-conference-call-transcript
Is it really possible to see the data before the FDA meeting?
IMO this scenario would answer the “Why is Tony working around the clock?” question.
Any logic when such a deal is likely to be signed? After PE data?
Thanks for your info.
One question, might not be able to answer:
Weren’t they completely focused on combo enrollment? I assume finding these patients and running these trials also require money right? This is starting to become really really interesting.
Toronto
FDA more than once mentioned they want to work with CYDY. BTD and fast track etc must come together if the data is strong.
I agree with Saltz, we are damn lucky to have Tony on board (and D. Burger). I’d be very scared if Nadar would still be in place. He’s been great to get where we are, but now it’s time for the big boys to finish it.
Hope they will have a positive CC!
I’d love to see this chart become a reality over the next 6 months. Or skip it all and see the BO price in a PR
Thanks for your message. I was just joking to Fred. Of course they will need to dilute.
Raise the complete amount of 60m will hurt SP but will derisk for some.
Keep raising small amount at every milestone will keep the lit on sp for as long as it goes.
All IMO
Hey Fred, do you think we have to raise more money?
?
Hope we see more PRs soon
Exactly!!!! Awesome news. Could we see more results coming in while waiting for FDA meeting?
Yes read that “Good news travels slowly, bad news has wings.” quote a while ago. I think it nails it for CYDY.
Can’t wait for the launch
Spot on
Aren’t the 30 patients divided in two groups:
Half on placebo and other half on Pro 140?
“PRO 140 administered as a single agent provided maximal virologic suppression and was well tolerated by 10 HIV-infected patients for nearly two years.”
http://ir.cytodyn.com/press-releases/detail/254/data-presented-at-croi-show-cytodyns-pro-140-as-a-single
Thanks again for your answers.
Lol at least we now get an extra PR:
“CYDY completes enrollment after FDA said it looked great”
Thanks a lot for your reply.
We’d have to see a small raise to get through to September right? Not sure if Tony is allowed to chip in again at this stage. Then Paulson would make sense.
Would the FDA talk [in the coming weeks] be about both combo and mono data?
Saltz you mentioned earlier they weren’t planning to release a PR, they didn’t see the advantage as it were a non event.
There must be something up since they felt the need to PR. Not sure negative or positive.
Also I remember from previous PR that the FDA requested to contact them as soon as they were done with filling combo.
Haha lol. Hope so too. Great price. Who would have guessed that we would have a fire sale this late in the game?
Personally was expecting more of an upward momentum. And don’t like this vacuum we are in.
I hope soon we are laughing all the way to the bank. The current state of SP is beyond me.
Or Cydy isn’t great in their PR strategy. Or they can’t say anything. From previous PR’s they must have updates on GvHD and colon cancer.
I’d love to know the answer to this question. Maybe we see a small insider round again right before results ;)
I added some again as well
We should also see some documents if one signs a NDA right?
Agree. All depends if GvHD is sold with it.
Nothing today either.
Reading through your posts it makes zero sense what you are saying/doing.
Makes perfect sense to sell all shares now. Right about when data will be made public. Lol
Thanks for the value you bring to this board.
Thanks for your post. One question:
“The primary focus of the management is a BO by BP.”
Which management; Paulson’s or Cytodyn’s?
Question, hopefully not too stupid.
Will the safety data of the 100 in mono study help broaden the label of the combo treatment?
Please look at previous posts on this board on RS. So many companies screw up their shareholders with RS. Not saying this one will.
One co I had holdings in was Gevo. Did 3 RS to bring SP above $1 to stay on the stock exchange and now the SP is again below 1. That means 4th RS will be coming. Also continues to raise cash. Very very dilutive and bad for your health ;) Again not saying CYDY is the same co.
93k on the bid at .71
Also they must discuss the labeling with the FDA in the coming weeks, since PRO 140 has more potential:
Orphan Drug Designation (ODD) was not granted by the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) because PRO 140 appears to have the potential to treat more than just the subset of multi-drug resistant HIV patients for which the designation was requested.
Personally I think the PR was great. It finally shuts down any chatter of “they will never finish enrollment”.
Now we have set timeline(s). On the latest call Tony was VERY clear about how long and how much money it would take to finish. Since he took over CYDY is right on time: “90% sure finish enrollment in q2”.
Also the +100 in MONO is awesome. They mentioned they wouldn’t be focused on this until they finished COMBO. And here we are. I believe this means the company can also talk with the FDA about safety data. Very important: as others mentioned since this is an open trial, so anything can happen from now on.
The question that keeps popping up is: “What is Tony working on around the clock?”
We should also hear more info on the GvhD and Cancer studies soon as well. This should be done in partnership.
Finally from a TA point of view; yesterday there were more buys over sells. Chart seems ready for a pop (imho).
And Saltz...
People want to get out on a spike, because a raise is over our heads. I wasn’t expecting a pop (although would have been nice).
Can’t wait for the real data to show up.
Just want to put it out there: I love Jody
Boom (Jody was right after all)
http://ir.cytodyn.com/press-releases/detail/262
CytoDyn Provides Update on Enrollment in its Pivotal Phase 2b/3 HIV Combination Trial
Download PDF
VANCOUVER, Washington, Aug. 09, 2017 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, today announced that 33 patients are currently enrolled in its pivotal Phase 2b/3 combination therapy trial. The Company has been in ongoing dialogue with the U.S. Food and Drug Administration (FDA) regarding the number of patients enrolled in the trial. Patient enrollment will remain open in the trial until CytoDyn holds a teleconference meeting with the FDA to discuss patient enrollment and analysis of data from the trial. The meeting is expected to be held in the coming weeks.
CytoDyn’s pivotal Phase 2b/3 trial combination trial is evaluating PRO 140 with current standard of care antiretroviral therapy (ART). The trial protocol requires enrollment of 30 patients for the purpose of assessing the trial’s primary efficacy endpoint, which is reached at one week following initial treatment with PRO 140. The safety portion of the Phase 2b/3 trial continues for an additional 24 weeks. CytoDyn expects to complete the clinical portion of its first Biological License Application (BLA) submission during the first half of 2018.
“We are optimistic about achieving the primary efficacy endpoint in this combination trial given our prior clinical experience with PRO 140,” said Nader Pourhassan, Ph.D., CytoDyn President and Chief Executive Officer. “We look forward to announcing these results and advancing the further development of PRO 140 as a treatment for HIV.”
CytoDyn is also conducting a 300-patient Phase 2b/3 trial with PRO 140 as a single agent to replace the current standard of care ART and enrollment currently exceeds 100 patients.
Added a thousand as well.
Someone offloaded. There goes the SP
I’m hoping saltz is right, that they want to use RS as the last resort. I seriously hope they can uplist organically.
I’m hoping for a partnership, I know it’s dilutive, but it takes out a lot of the risk.
Most interesting month in CYDY ever. If there’s one time to say a golden quarter, it’s this time. I love that they’re quiet, since Tony promised to be more communicative.
1. Close the offering.
2. PR great results
3. Do another offering at higher SP (shouldn’t they let us know how much at what amount?)
4. Raise money (for both uplist and trials)
5. RS
6. Uplist
Not sure if this is the right outcome for us
I think Saltz is right that they choose not to PR. Thanks you again for all your input.
The two things an “Enrollment PR” would have done were:
1. Set the timer to 4 weeks;
2. Created upward momentum.
Tried to think of logical scenarios on why not to PR, but they didn’t make sense. Please share if anyone does.
The situation is that we don’t know anything and end of August we will wake up to a PR. I’m fine with that.
About the images, I just wanted to prove that it wasn’t bullshit from my side that she responded.